Associate Director driving JOLT's media analytics strategy across North America and the UK. Building audience intelligence and insights for commercial success in a expanding markets.
About the role
- Lead diagnostics development and commercialization for GSK's Oncology portfolio. Manage cross-functional teams to deliver innovative diagnostics while ensuring compliance with regulations.
Responsibilities
- Manage the team of associate directors, diagnostics.
- Team manager to deliver on the vision of equipping GSK to be a leader in oncology through Dx development driving the portfolio value
- Monitor and report projects progress, outcomes, KPIs eg delivery of Target Diagnostic Profile
- Remove barriers to Dx strategy development and implementation, collaborating cross functionally with clinical operations, external engagement, procurement, etc…
- Exhibits timely management and delivery of projects/work streams within agreed budget.
- Must be able to manage multiple projects and work streams across TAs and R&D, including assessment of workload and resourcing requirements to deliver the team’s objectives.
- Clearly and concisely report project progress and outcomes, coordinating with project management, finance and business operations
- Ensure learnings and best practices are shared and adopted for effective delivery
- Participate in the evaluation of advanced technologies for IVD and clinical biomarker development
- Keep a pulse on team execution and cross-functional ways of working with clinical, regulatory, operations, policy, BD and business unit colleagues and key leadership within project teams
- Provides frequent project status updates / reports related to Dx deliverables. Where applicable, accountable for implementing key organizational process improvement initiatives in daily activities
Requirements
- Ph.D. in Biological Sciences and 5 years of pharmaceutical and/or diagnostic industry experience or B.S or M.S. with 7 years of pharmaceutical and diagnostic industry experience
- Experience in drug / diagnostic development especially late stage development, regulatory approval and life cycle management (eg follow on Dx)
- Experience with technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies)
- Experience in IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements
- Experience performing due diligence and audit of Dx developers
- Experience with GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements
- Experience with QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations
- Experience with clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management)
- Experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as MS Teams
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
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